What Is Leqvio?
Leqvio (inclisiran) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
What Are Side Effects of Leqvio?
Side effects of Leqvio include:
- injection site reactions (pain, redness, rash),
- joint pain,
- urinary tract infection (UTI),
- pain in extremities, and
- shortness of breath.
Dosage for Leqvio
The recommended dosage of Leqvio, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months. Leqvio should be administered by a healthcare professional.
Leqvio In Children
The safety and effectiveness of Leqvio have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Leqvio?
Leqvio may interact with other medicines.
Tell your doctor all medications and supplements you use.
Leqvio During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Leqvio. Discontinue Leqvio when pregnancy is recognized. It is unknown if Leqvio passes into breast milk. Consult your doctor before breastfeeding.
Our Leqvio (inclisiran) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in Table 1 are derived from 3 placebo-controlled trials that included 1833 patients treated with LEQVIO, including 1682 exposed for 18 months (median treatment duration of 77 weeks) [see Clinical Studies]. The mean age of the population was 64 years, 32% of the population were women, 92% were White, 6% were Black, 1% were Asian, and < 1% were other races. At baseline, 12% of patients had a diagnosis of heterozygous familial hypercholesterolemia and 85% had clinical atherosclerotic cardiovascular disease.
Adverse reactions reported in at least 3% of LEQVIO-treated patients, and more frequently than in placebo-treated patients, are shown in Table 1.
Table 1: Adverse Reactions Occurring in Greater Than or Equal to 3% of LEQVIO-treated Patients and More Frequently than with Placebo (Studies 1, 2, and 3)
(N = 1822) %
(N = 1833) %
|Injection site reaction†||1.8||8.2|
|Urinary tract infection||3.6||4.4|
|Pain in extremity||2.6||3.3|
|†includes related terms such as: injection site pain, erythema and rash|
Adverse reactions led to discontinuation of treatment in 2.5% of patients treated with LEQVIO and 1.9% of patients treated with placebo. The most common adverse reactions leading to treatment discontinuation in patients treated with LEQVIO were injection site reactions (0.2% versus 0% for LEQVIO and placebo, respectively).
As with all oligonucleotides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
The immunogenicity of LEQVIO has been evaluated using screening and confirmatory immunoassays for the detection of binding anti-drug antibodies to LEQVIO.
In the placebo-controlled clinical trials, 1830 patients had samples tested for anti-drug antibodies. Confirmed positivity was detected in 33 (1.8%) patients prior to dosing and in 90 (4.9%) patients during the 18 months of treatment with LEQVIO. Approximately 31 (1.7%) inclisiran-treated patients with a negative sample at baseline had a persistent anti-drug antibody response, defined as two confirmed positive samples separated by at least 16 weeks or a single confirmed positive final sample. There was no evidence that the presence of anti-drug binding antibodies impacted the pharmacodynamic profile, clinical response, or safety of LEQVIO, but the long-term consequences of continuing LEQVIO treatment in the presence of anti-drug binding antibodies are unknown.
No Information provided
Read the entire FDA prescribing information for Leqvio (Inclisiran Injection)
© Leqvio Patient Information is supplied by Cerner Multum, Inc. and Leqvio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors